What is USFDA Purple Book? What it’s significance?
Posted on19 Nov 2019
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The “Purple Book” lists biological products, including any biosimilar and interchangeable biological products, licensed by FDA under the Public Health Service Act... Read More
USFDA approved Pfizer’s Abrilada, a biosimilar of Humira
Posted on19 Nov 2019
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The U.S. Food and Drug Administration (FDA) approved Pfizer’s Abrilada, a biosimilar of Humira. Pfizer said the FDA approved Abrilada (adalimumab-afzb) for the treatment of... Read More
Biocon, Mylan launch first insulin glargine biosimilar, Semglee in Australia
Biocon Ltd and Mylan N.V. announced the launch of Semglee (insulin glargine solution for injection 100 IU/mL in a 3mL pre-filled pen),... Read More
USFDA approval of Rituxan, in combination with glucocorticoids, for the treatment of granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in paediatric patients 2 years of age and older
Roche announced that the US Food and Drug Administration (FDA) has approved Rituxan (rituximab), in combination with glucocorticoids, for the treatment of... Read More
Case Study: USFDA approval of AbbVie’s RINVOQ (upadacitinib)
U.S. Food and Drug Administration (FDA) has approved RINVOQ™ (upadacitinib), a 15 mg, once-daily oral Janus kinase (JAK) inhibitor, for the treatment... Read More
List of USFDA approved Biosimilar [till date]
Click here to view the list.
US FDA approves Pfizer’s Biosimilar Zirabev
Pfizer Inc announced the US FDA has approved Zirabev (bevacizumab-bvzr), a biosimilar to Avastin (bevacizumab), for the treatment of five types of... Read More
Top 10 Generic Company Globally in 2018 (by revenue)
Here you can preview top 10 global generic companies by revenue. Data is presented in USD million. Click here to view the... Read More
Take a self competency test in authorized generics
In the U.S., prescription drugs approved by the federal Food and Drug Administration (FDA) are granted a specified period of market exclusivity,... Read More
Health Canada approves Biocon and Mylan’s trastuzumab biosimilar ‘Ogivri’ for HER2-positive cancers
Biocon and Mylan have received the clearance from Health Canada for the latter’s biosimilar Herceptin: trastuzumab co-developed under the brand name Ogivri... Read More